Hodgkin Lymphoma (Category)Phase 2BASTIONNCT06919679
Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma
A Phase 2 study testing BrECADD in people with Hodgkin Lymphoma (Category), run by University of Cologne.
Trial summary
Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma (Category)
- What is being tested?
- BrECADD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histologically confirmed first diagnosis of cHL
- Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
- No previous treatment for HL with the exception of steroid prephase
- Confirmed HIV infection with CD4 counts ≥ 150/μL at registration or > 250/μL at any time within 8 months prior to HL diagnosis
- Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naive
- Age: 18-60 years
Who cannot join
- Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment
- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
- Multi-drug resistant HIV infection or concurrent AIDS-defining conditions
- Pregnancy or breastfeeding
About this study
Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. A second restaging will be performed after completion of chemotherapy. In patients with PET-positive residual disease, local irradiation followed by another restaging is recommended. ART should be continued during chemotherapy.
- Conditions
- Hodgkin Lymphoma (Category)
- Being tested
- BrECADD
- Keywords
- advanced stage, HIV positive, Brentuximab Vedotin
- Medical subject headings
- Hodgkin Disease, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrECADDDrug
Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. Receives: Drug: BrECADD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: PFS at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma (Category)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Peter Borchmann, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919679
- Sponsor's protocol ID
- Uni-Koeln-5576
- Other IDs
- 2025-521749-26-00, 2025
- Acronym
- BASTION
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06919679
- Acronym / sponsor ID
- BASTION / Uni-Koeln-5576
- Conditions
- Hodgkin Lymphoma (Category)
- Keywords
- advanced stage, HIV positive, Brentuximab Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. A second restaging will be performed after completion of chemotherapy. In patients with PET-positive residual disease, local irradiation followed by another restaging is recommended. ART should be continued during chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BrECADDParticipants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Histologically confirmed first diagnosis of cHL
- Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
- No previous treatment for HL with the exception of steroid prephase
- Confirmed HIV infection with CD4 counts ≥ 150/μL at registration or > 250/μL at any time within 8 months prior to HL diagnosis
- Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naive
Key exclusion criteria (4 listed)
- Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment
- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
- Multi-drug resistant HIV infection or concurrent AIDS-defining conditions
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrECADDBrentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone | Drug | Treatment |
Primary outcome
Progression Free Survival
Time frame: PFS at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BrECADD in people with Hodgkin Lymphoma (Category), run by University of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: PFS at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.